Recall: D-0556-2026

Class II - Potentially Harmful

Class IIClassification

2026-05-05Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

Product

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.

Reason

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.